Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781400
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2021-02-22
Brief Title:
Bidirectional Upbeat Communication and Differentiated Distanced Care for Young People
Sponsor:
Desmond Tutu HIV Foundation
Organization:
Desmond Tutu HIV Foundation
Study Overview
Official Title:
Bidirectional Upbeat Communication and Differentiated Distanced Care for Young People
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUDDY
Brief Summary:
Sub Saharan Africa is home to only 12 of the population but accounts for approximately 70 of the global burden of HIV infection and 84 of infections among young people aged 10-24 years South Africa which currently has the largest SARS-CoV-2 pandemic in SSA also has the largest HIV epidemic globally Access and service delivery barriers to engaging in HIV care have contributed to estimates that only 49 of adolescents aged 10-19 years entering care from 2005-2016 have initiated antiretroviral therapy ART In response to the SARS-CoV-2 pandemic the South African government has implemented national lock-down orders that we predict will further inhibit treatment engagement among young people Research is needed to identify best practices for safely retaining young people living with HIV YPLWH in care during COVID-19
Detailed Description:
The primary objectives of this study are to examine the feasibility acceptability and preliminary efficacy of a remote service delivery model for young people living with HIV aged 13-24 years that will include a monthly service needs assessment and optional delivery of HIV treatment services YPLWH will also be randomized to receive or not receive mobile check-ins from study staff and access to two-way messaging capabilities to obtain continuous support for adherence to ART and COVID-19 prevention guidelines
Investigators will also assess the impact of the COVID-19 lock-down orders on multi-level factors individual socio-behavioral structural over time among young people aged 13-24 years living with HIV same cohort as above and without HIV Particular focus will be given to experience and perpetration of gender based violence In addition investigators will assess the impact of multi-level factors on compliance with COVID-19 prevention guidelines health service utilization and engagement in HIV care YPLWH only Findings will be examined overall and stratified by HIV status and gender
Ultimately investigators hope to i determine whether a remote service delivery model will help retain young people in HIV care and ii Inform the development of an intervention for young people in the study communities who may be experiencing GBV and associated outcomes in the wake of the pandemic
Investigators will also assess the impact of the COVID-19 lock-down orders on multi-level factors individual socio-behavioral structural over time among young people aged 13-24 years living with HIV same cohort as above and without HIV Particular focus will be given to experience and perpetration of gender based violence In addition investigators will assess the impact of multi-level factors on compliance with COVID-19 prevention guidelines health service utilization and engagement in HIV care YPLWH only Findings will be examined overall and stratified by HIV status and gender
Ultimately investigators hope to i determine whether a remote service delivery model will help retain young people in HIV care and ii Inform the development of an intervention for young people in the study communities who may be experiencing GBV and associated outcomes in the wake of the pandemic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None